MALVERN, Pa., May 22 /PRNewswire-FirstCall/ -- Auxilium Pharmaceuticals, Inc. (NASDAQ:AUXL) today announced that new data show improvements in symptoms of decreased libido, energy levels and erectile function in 76 percent of hypogonadal men after switching brands of testosterone replacement gel therapy. Total testosterone levels increased significantly in patients who switched to Auxilium's Testim(R) 1% (testosterone gel) following suboptimal response to Solvay S.A.'s Androgel(R) (testosterone gel) 1%, according to research presented today at the annual meeting of the American Urological Association, the largest meeting in the world of urology health care professionals, in Anaheim, California.
In a retrospective study conducted at Baylor College of Medicine, records of 370 hypogonadal men on once-daily testosterone gel replacement therapy (Testim or AndroGel) were reviewed to identify patients who could be evaluated for the efficacy of substitution to the alternate brand of therapy due to an initial suboptimal biochemical or symptomatic response, adverse effect or patient preference.
"Patients using testosterone replacement gel therapy sometimes will fail to respond to their current treatment, resulting in persistent hypogonadal symptoms and a sub-optimal increase in testosterone blood levels," said Larry I. Lipshultz, M.D., Professor of Urology and Chief of the Division of Male Reproductive Medicine and Surgery at Baylor College of Medicine. "These data support changing testosterone gel preparations among initially unresponsive patients prior to abandoning or considering more invasive testosterone replacement therapy."
Study Design and Key Findings
Of the 370 records of hypogonadal men that were identified on testosterone gel therapy, 70 (19%) underwent a brand substitution in testosterone gel treatment. Eighty-one percent switched from Androgel to Testim, and 19 percent switched from Testim to Androgel. Total serum testosterone (T), free testosterone (FT), and the presence of hypogonadal symptoms (libido, energy levels, and erectile function) were compared pre-and post-substitution for each form of therapy.
Prior to gel substitution, patients initially treated with AndroGel had mean T and FT levels of 314ng/dl and 10.2pg/ml, respectively, and total testosterone levels were below 300ng/dl in 57 percent of patients. Among patients who were initially treated on Testim, the mean T and FT levels were 444ng/dl and 14.6pg/ml, respectively, and total testosterone levels were below 300ng/dl in 18 percent of men.
Following testosterone gel substitution: -- Total testosterone levels increased significantly following a switch from AndroGel to Testim, but not from Testim to AndroGel. -- The mean increase in T and FT was 174ng/dl (p=0.003) and 3.3pg/ml (p=0.14), respectively, among men switched to Testim, and 1.0ng/dl (p=0.9) and 0.3pg/ml (p=0.9), respectively, among men switched to AndroGel. -- Hypogonadal symptoms improved in 76 percent of men who underwent a brand substitution following an initial inadequate response.
Low testosterone ("Low T"), or hypogonadism, is a medical condition caused by disease or damage to the testicles, hypothalamus, or pituitary gland that inhibits hormone secretion and testosterone production. Physical signs of hypogonadism can include incomplete sexual development, body hair loss, reduced muscle bulk and increased body fat, height loss, low bone density and impaired sperm production. Symptoms associated with hypogonadism can include reduced sexual desire, depression, changes in mood, poor concentration, decreased energy and motivation, and increased sleepiness. A study in The International Journal of Clinical Practice was published in 2006 that showed 39% of men over 45 years of age have low testosterone (total testosterone levels below 300 ng / dL). We estimate that less than 10% of men with hypogonadism currently receive testosterone replacement therapy.
Testim is a proprietary, clear, topical gel containing 1% testosterone, the same type of hormone that is produced by the human body. When applied once-daily to the upper arms and shoulders, clinical studies have shown that Testim will restore and maintain testosterone levels. Once Testim is absorbed through the skin, it enters the bloodstream and helps return testosterone to normal levels. The efficacy of Testim has been demonstrated in 16 clinical studies involving approximately 1,800 patients, including the largest placebo- controlled study ever conducted to evaluate the benefits and risks of testosterone replacement therapy. For information regarding the safety and use of Testim, please see the prescribing information at http://www.testim.com.
Auxilium Pharmaceuticals, Inc. is a specialty biopharmaceutical company with a focus on developing and marketing to urologists, endocrinologists, orthopedists and select primary care physicians. Auxilium markets Testim(R) 1%, a topical testosterone gel, for the treatment of hypogonadism through its approximately 190-person sales and marketing team. Auxilium has four projects in clinical development. AA4500, an injectable collagenase enzyme, is in phase III of development for the treatment of Dupuytren's contracture and is in phase II of development for the treatment of Peyronie's disease and Frozen Shoulder syndrome (Adhesive Capsulitis). Auxilium's transmucosal film product candidate for the treatment of overactive bladder (AA4010) is in phase I of development. The Company is currently seeking a partner to further develop this product candidate. Auxilium has two pain products using its transmucosal film delivery system in pre-clinical development. Auxilium has rights to six additional pain products and products for hormone replacement and urologic disease using its transmucosal film delivery system, and options to all indications using AA4500 for non-topical formulations. For additional information, visit http://www.auxilium.com.
SAFE HARBOR STATEMENT
This release contains "forward-looking-statements" within the meaning of The Private Securities Litigation Reform Act of 1995, including statements regarding the interpretation of clinical data, the number of men being treated for hypogonadism, the Company's products in development for the treatment of Dupuytren's contracture, Peyronie's disease, Frozen Shoulder syndrome, pain, hormone replacement and urologic disease. All statements other than statements of historical facts contained in this release, including but not limited to, statements regarding future expectations, plans and prospects for the Company, statements regarding forward-looking financial information and other statements containing the words "believe," "may," "could," "will," "estimate," "continue," "anticipate," "intend," "should," "plan," "expect," and similar expressions, as they relate to the Company, constitute forward-looking statements. Actual results may differ materially from those reflected in these forward-looking statements due to various factors, including general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries and those discussed in the Company's Annual Report on Form 10-K for the year ended December 31, 2006 and in the Company's Quarterly Report on Form 10-Q for the period ended March 31, 2007 under the heading "Risk Factors", which is on file with the Securities and Exchange Commission (the "SEC") and may be accessed electronically by means of the SEC's home page on the Internet at http://www.sec.gov or by means of the Company's home page on the Internet at http://www.auxilium.com under the heading "Investor Relations -- SEC Filings." There may be additional risks that the Company does not presently know or that the Company currently believes are immaterial which could also cause actual results to differ from those contained in the forward-looking statements. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward- looking statements.
In addition, forward-looking statements provide the Company's expectations, plans or forecasts of future events and views as of the date of this release. The Company anticipates that subsequent events and developments will cause the Company's assessments to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward- looking statements should not be relied upon as representing the Company's assessments as of any date subsequent to the date of this release.
Source: Auxilium Pharmaceuticals, Inc.